The document summarizes the African Medicines Regulatory Harmonisation (AMRH) Initiative. It discusses the background and vision of AMRH, which aims to improve access to essential medicines through regulatory harmonization across Africa. It outlines achievements including establishing an advisory committee and technical working groups, developing a model law, and launching regulatory harmonization projects in several regions. The document also notes industry support for AMRH and how regulatory harmonization can boost healthcare, access to new drugs, and the pharmaceutical industry in Africa over the short and long term. It concludes by highlighting next steps such as expanding the scope of harmonization and establishing sustainable training programs.
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
REGULATORY REQUIREMENTS FOR ASEAN COUNTRIESVikas Rathee
The document discusses regulatory requirements for drug registration in Asian countries. It provides an overview of the ASEAN Common Technical Dossier (ACTD) format for drug applications across ASEAN countries. It then summarizes requirements for registration in China, South Korea, and with the ASEAN region. For China, it outlines the drug classification system and two-step approval process. For South Korea, it describes the drug classification and approval process including investigational new drug applications. It also provides background on the goals and formation of the ASEAN economic alliance between Southeast Asian countries.
This document summarizes registration requirements for medicines in three CIS countries - Uzbekistan, Georgia, and Kyrgyzstan. Uzbekistan requires chemical, pharmaceutical, biological, pharmacological, toxicological and clinical documentation be submitted. Georgia requires administrative documents, labeling information approved in the exporting country, and samples. Kyrgyzstan requires an application, power of attorney, GMP certificate, product description and stability data. All three countries require documentation be submitted in their local languages and require stability testing in Zone I conditions.
Marketing Authorization Procedure in European UnionDoninder Hooda
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
This presentation contains information about dossier preparation and submission as well as about CTD (Common Technical Document) which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
This document provides an overview of the electronic Common Technical Document (eCTD) format used for regulatory drug submissions. It discusses the history and goals of the ICH and eCTD, the components and structure of an eCTD, best practices for preparing documents, and software options. Key points covered include the folder structure, use of XML and metadata, concept of reuse and granularity, and comparing the benefits of eCTD to traditional paper submissions. The conclusion emphasizes that adopting eCTD is essential to joining the electronic bandwagon, while also needing intermediate steps to fully transition from paper CTD formats.
MedWatch is the FDA's program for monitoring the safety of medical products. It allows voluntary reporting of adverse events by the public and healthcare professionals. Reports are collected in a database and monitored by FDA professionals. The FDA uses these reports to identify safety issues, communicate new safety information to the public and healthcare providers, and take regulatory actions like requiring label changes or product recalls when needed. The goal is to help protect public health by ensuring the safety of drugs, medical devices and other medical products.
overview of Japan pharmaceutical regulatory authority - PMDANandhanan
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare.
Its obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.
It conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety and also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.
REGULATORY REQUIREMENTS FOR ASEAN COUNTRIESVikas Rathee
The document discusses regulatory requirements for drug registration in Asian countries. It provides an overview of the ASEAN Common Technical Dossier (ACTD) format for drug applications across ASEAN countries. It then summarizes requirements for registration in China, South Korea, and with the ASEAN region. For China, it outlines the drug classification system and two-step approval process. For South Korea, it describes the drug classification and approval process including investigational new drug applications. It also provides background on the goals and formation of the ASEAN economic alliance between Southeast Asian countries.
This document summarizes registration requirements for medicines in three CIS countries - Uzbekistan, Georgia, and Kyrgyzstan. Uzbekistan requires chemical, pharmaceutical, biological, pharmacological, toxicological and clinical documentation be submitted. Georgia requires administrative documents, labeling information approved in the exporting country, and samples. Kyrgyzstan requires an application, power of attorney, GMP certificate, product description and stability data. All three countries require documentation be submitted in their local languages and require stability testing in Zone I conditions.
Marketing Authorization Procedure in European UnionDoninder Hooda
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
This presentation contains information about dossier preparation and submission as well as about CTD (Common Technical Document) which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
This document provides an overview of the electronic Common Technical Document (eCTD) format used for regulatory drug submissions. It discusses the history and goals of the ICH and eCTD, the components and structure of an eCTD, best practices for preparing documents, and software options. Key points covered include the folder structure, use of XML and metadata, concept of reuse and granularity, and comparing the benefits of eCTD to traditional paper submissions. The conclusion emphasizes that adopting eCTD is essential to joining the electronic bandwagon, while also needing intermediate steps to fully transition from paper CTD formats.
MedWatch is the FDA's program for monitoring the safety of medical products. It allows voluntary reporting of adverse events by the public and healthcare professionals. Reports are collected in a database and monitored by FDA professionals. The FDA uses these reports to identify safety issues, communicate new safety information to the public and healthcare providers, and take regulatory actions like requiring label changes or product recalls when needed. The goal is to help protect public health by ensuring the safety of drugs, medical devices and other medical products.
This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
The document discusses guidelines for Active Substance Master Files (ASMF) and European Drug Master Files (EDMF) in the European Union. Some key points:
- An ASMF/EDMF contains quality and quality control information for an active pharmaceutical ingredient. It has two parts - an applicant part given to marketing authorization applicants, and a restricted part for regulatory authorities.
- The ASMF procedure can be used for new active substances, existing substances not in pharmacopeias, and pharmacopeial substances. It cannot be used for biological substances.
- Marketing authorization applicants must include specified information from the ASMF in their application dossier and have access to the current active substance manufacturer. ASMF
The document discusses electronic common technical document (eCTD), which is the electronic equivalent of the common technical document for submitting regulatory information to health authorities. It describes what eCTD is, why it is used, its history and adoption by different regions. It also explains the modules, components and general considerations for compiling an eCTD submission. Specific requirements for submitting to the EU and US are provided. Challenges of implementing eCTD include the need for tools, training and adapting to changes in the submission process.
This document discusses recommendations for post-approval changes to approved drug applications. It defines major, moderate, and minor changes and provides examples. Major changes require prior approval from the FDA before distribution. Moderate changes require submission of a supplement to the FDA either 30 days or 60 days before distribution depending on the type of change. Minor changes are described in annual reports. The document provides recommendations for changes in several areas including components and manufacturing processes, specifications, packaging, labeling, and multiple related changes. It also notes some of the major differences in requirements for changes to biological products versus drug products.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
The European Medicines Agency (EMA) regulates medicines for both human and veterinary use across Europe. Key responsibilities of EMA include evaluating applications for new medicines and monitoring approved medicines. EMA operates through various scientific committees and follows regulatory procedures for clinical trials and marketing authorization applications. EMA helps ensure that medicines available across Europe are safe, effective and of high quality.
Regulatory dossier preparation and submission as per CTD formatAvinash sharma
This document provides an overview of regulatory dossier preparation and submission using the Common Technical Document (CTD) format. It defines a regulatory dossier and describes the two main types: ICH-CTD and ASEAN CTD. It lists several countries and their respective regulatory authorities. The CTD is explained as a joint format maintained by regulatory agencies in Europe, Japan, and the US. The five CTD modules are outlined which contain administrative, quality, non-clinical, and clinical information. Finally, it compares paper, NeeS, and eCTD submission formats in terms of features like type, compilation, and submission method.
The document filing for a pharmaceutical product is done in the form of dossier. The slides explain the format and content to be included in all the formats of dossiers.
This document discusses Drug Master Files (DMFs), which contain confidential information about drug components submitted to regulatory agencies like the FDA. It describes the five types of DMFs, including Type II for drug substances, Type III for packaging materials, and Type IV for excipients. The document outlines the roles of DMF holders, applicants, and agencies and review procedures to ensure quality, safety and efficacy of drug products.
The document provides an overview of Drug Master Files (DMFs) and Certificates of Suitability (CEPs) for drug substances. It describes that a DMF is a confidential submission to regulatory agencies containing manufacturing and quality control information about a substance or component. It discusses the different types of DMFs, how they are submitted and reviewed, annual reporting requirements, and retirement. It also describes that a CEP is issued by EDQM and demonstrates that a substance's purity is controlled according to European Pharmacopoeia monographs, easing approval in Europe.
The document provides information on documentation practices in the pharmaceutical industry. It discusses why documentation is important, defining documentation as written evidence of activities. It states that regulatory bodies prioritize reviewing documents to verify activities. Good documentation practices, including systematic preparation and review of documents, are required to prevent errors and ensure compliance. Documentation provides records, traceability, and audit trails for investigation and review.
The document discusses New Drug Applications (NDAs) submitted to the FDA for approval of new drug products. It describes how NDAs contain data from animal and human clinical trials demonstrating a drug's safety and effectiveness. There are different types of NDAs depending on if a drug is novel or similar to existing drugs. The FDA reviews NDAs to determine if manufacturing is adequate and if a drug's benefits outweigh its risks based on the application contents and recommendations are made for approval or further work required. Approved drugs require ongoing safety monitoring and reporting to the FDA.
This document summarizes the key points about drug master files (DMFs), including the different types of DMFs, their essential contents, and how they are submitted and reviewed. There are 5 types of DMFs that provide information about manufacturing facilities and controls, drug substances and products, packaging materials, and excipients. A DMF is submitted to regulatory authorities by a holder and can be referenced by applicants in applications like NDAs or ANDAs. It includes administrative and technical information and requires a letter of authorization for the applicant.
Clinical Research Regulation in European Union ShantanuThakre3
The document discusses clinical research regulations in the European Union. It provides information on the aim of the European Medicines Agency (EMA) in regulating clinical trials to protect subjects' rights and safety. It describes the EMA's role in ensuring good clinical practice standards across the European Economic Area. It also summarizes key points of the new Clinical Trials Regulation, including requirements for authorization, informed consent, and conducting trials on vulnerable groups. Finally, it discusses the Clinical Trials Information System that will support application and oversight of trials under the new Regulation.
This document discusses various post-approval requirements and processes for pharmaceutical drugs, including prior approval supplements, changes being effected in 30 days supplements, annual reports, labeling changes, recalls, FDA inspections, and ISO 31000 risk management standards. It provides details on submission requirements and timelines for different types of post-approval changes, as well as FDA enforcement actions like warning letters, seizures, and injunctions.
This document provides information about drug master files (DMFs), including their definition, regulatory requirements, types, specifications, content, and submission process. A DMF is a confidential document containing details about the manufacturing and controls of an active pharmaceutical ingredient. There are five types of DMFs which provide information about drug substances, packaging materials, excipients, and other reference information. A Type II DMF for a drug substance must be organized according to ICH guidelines and contain manufacturing details, characterization, specifications, and stability data. Amendments and annual reports are used to update the information in a DMF.
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
The document discusses post-approval changes that can be made to approved NDAs and ANDAs. It describes four reporting categories for post-approval changes based on their potential impact: major changes requiring prior approval, moderate changes reported via a CBE-30 or CBE-0 supplement, minor changes reported annually. Examples are provided for different types of changes that fall under each reporting category. The levels of reporting ensure that manufacturers can make certain changes while providing appropriate notification to the FDA depending on the level of change.
The document provides an overview of efforts to implement the Pharmaceutical Manufacturing Plan for Africa (PMPA) through the African Medicines Regulatory Harmonization initiative (AMRH). It discusses:
1) The background and principles of PMPA which aim to strengthen Africa's pharmaceutical industry and regulatory systems.
2) Challenges in Africa's pharmaceutical value chain like ineffective regulation and technical barriers.
3) NEPAD Agency's role in supporting PMPA implementation through policy/regulatory reforms and capacity development under AMRH.
4) Progress made in establishing AMRH projects across African regions to harmonize medical product registration and regulatory functions.
5) The vision for A
Presentation by medicines registration harmonisation in the SADC made at the Euro-Africa Health Investment Conference, March 26 - 27, 2013, London, United Kingdom.
This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
The document discusses guidelines for Active Substance Master Files (ASMF) and European Drug Master Files (EDMF) in the European Union. Some key points:
- An ASMF/EDMF contains quality and quality control information for an active pharmaceutical ingredient. It has two parts - an applicant part given to marketing authorization applicants, and a restricted part for regulatory authorities.
- The ASMF procedure can be used for new active substances, existing substances not in pharmacopeias, and pharmacopeial substances. It cannot be used for biological substances.
- Marketing authorization applicants must include specified information from the ASMF in their application dossier and have access to the current active substance manufacturer. ASMF
The document discusses electronic common technical document (eCTD), which is the electronic equivalent of the common technical document for submitting regulatory information to health authorities. It describes what eCTD is, why it is used, its history and adoption by different regions. It also explains the modules, components and general considerations for compiling an eCTD submission. Specific requirements for submitting to the EU and US are provided. Challenges of implementing eCTD include the need for tools, training and adapting to changes in the submission process.
This document discusses recommendations for post-approval changes to approved drug applications. It defines major, moderate, and minor changes and provides examples. Major changes require prior approval from the FDA before distribution. Moderate changes require submission of a supplement to the FDA either 30 days or 60 days before distribution depending on the type of change. Minor changes are described in annual reports. The document provides recommendations for changes in several areas including components and manufacturing processes, specifications, packaging, labeling, and multiple related changes. It also notes some of the major differences in requirements for changes to biological products versus drug products.
Comparison of Clinical Trial Application requirement of India, USA and Europe.Aakashdeep Raval
The document compares the clinical trial application requirements of India, the United States, and Europe. Some key differences include:
- Europe requires approval of a clinical trial application, while the US only requires an investigational new drug application be filed.
- India requires forms, documentation of chemical/toxicology data, and fees to be submitted with the application.
- The US, Europe, and India all require institutional review board or ethics committee approval before starting a trial.
- Reporting and retention of adverse events and trial records differs between the regions' regulations.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
The European Medicines Agency (EMA) regulates medicines for both human and veterinary use across Europe. Key responsibilities of EMA include evaluating applications for new medicines and monitoring approved medicines. EMA operates through various scientific committees and follows regulatory procedures for clinical trials and marketing authorization applications. EMA helps ensure that medicines available across Europe are safe, effective and of high quality.
Regulatory dossier preparation and submission as per CTD formatAvinash sharma
This document provides an overview of regulatory dossier preparation and submission using the Common Technical Document (CTD) format. It defines a regulatory dossier and describes the two main types: ICH-CTD and ASEAN CTD. It lists several countries and their respective regulatory authorities. The CTD is explained as a joint format maintained by regulatory agencies in Europe, Japan, and the US. The five CTD modules are outlined which contain administrative, quality, non-clinical, and clinical information. Finally, it compares paper, NeeS, and eCTD submission formats in terms of features like type, compilation, and submission method.
The document filing for a pharmaceutical product is done in the form of dossier. The slides explain the format and content to be included in all the formats of dossiers.
This document discusses Drug Master Files (DMFs), which contain confidential information about drug components submitted to regulatory agencies like the FDA. It describes the five types of DMFs, including Type II for drug substances, Type III for packaging materials, and Type IV for excipients. The document outlines the roles of DMF holders, applicants, and agencies and review procedures to ensure quality, safety and efficacy of drug products.
The document provides an overview of Drug Master Files (DMFs) and Certificates of Suitability (CEPs) for drug substances. It describes that a DMF is a confidential submission to regulatory agencies containing manufacturing and quality control information about a substance or component. It discusses the different types of DMFs, how they are submitted and reviewed, annual reporting requirements, and retirement. It also describes that a CEP is issued by EDQM and demonstrates that a substance's purity is controlled according to European Pharmacopoeia monographs, easing approval in Europe.
The document provides information on documentation practices in the pharmaceutical industry. It discusses why documentation is important, defining documentation as written evidence of activities. It states that regulatory bodies prioritize reviewing documents to verify activities. Good documentation practices, including systematic preparation and review of documents, are required to prevent errors and ensure compliance. Documentation provides records, traceability, and audit trails for investigation and review.
The document discusses New Drug Applications (NDAs) submitted to the FDA for approval of new drug products. It describes how NDAs contain data from animal and human clinical trials demonstrating a drug's safety and effectiveness. There are different types of NDAs depending on if a drug is novel or similar to existing drugs. The FDA reviews NDAs to determine if manufacturing is adequate and if a drug's benefits outweigh its risks based on the application contents and recommendations are made for approval or further work required. Approved drugs require ongoing safety monitoring and reporting to the FDA.
This document summarizes the key points about drug master files (DMFs), including the different types of DMFs, their essential contents, and how they are submitted and reviewed. There are 5 types of DMFs that provide information about manufacturing facilities and controls, drug substances and products, packaging materials, and excipients. A DMF is submitted to regulatory authorities by a holder and can be referenced by applicants in applications like NDAs or ANDAs. It includes administrative and technical information and requires a letter of authorization for the applicant.
Clinical Research Regulation in European Union ShantanuThakre3
The document discusses clinical research regulations in the European Union. It provides information on the aim of the European Medicines Agency (EMA) in regulating clinical trials to protect subjects' rights and safety. It describes the EMA's role in ensuring good clinical practice standards across the European Economic Area. It also summarizes key points of the new Clinical Trials Regulation, including requirements for authorization, informed consent, and conducting trials on vulnerable groups. Finally, it discusses the Clinical Trials Information System that will support application and oversight of trials under the new Regulation.
This document discusses various post-approval requirements and processes for pharmaceutical drugs, including prior approval supplements, changes being effected in 30 days supplements, annual reports, labeling changes, recalls, FDA inspections, and ISO 31000 risk management standards. It provides details on submission requirements and timelines for different types of post-approval changes, as well as FDA enforcement actions like warning letters, seizures, and injunctions.
This document provides information about drug master files (DMFs), including their definition, regulatory requirements, types, specifications, content, and submission process. A DMF is a confidential document containing details about the manufacturing and controls of an active pharmaceutical ingredient. There are five types of DMFs which provide information about drug substances, packaging materials, excipients, and other reference information. A Type II DMF for a drug substance must be organized according to ICH guidelines and contain manufacturing details, characterization, specifications, and stability data. Amendments and annual reports are used to update the information in a DMF.
DRUG MASTER FILE
Presented by :
RUSHIKESH D MENDHE
Roll no - 511
Mpharm Ist Year
(Department of Pharmaceutics)
Content : :
INTRODUCTION
TYPES OF DMF
DMF FORMAT & ASSEMBLY
DELIVERY OF DMF TO FDA
SUBMISSION OF DMF
THE MECHANISM OF A DRUG MASTER FILE
CTD & ELECTRONIC DMFS
UPDATES TO DMF
CLOSURE OF A DRUG MASTER FILE
APPLICATION OF DMF
REFERENCE
INTRODUCTION :
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
This guideline does not impose mandatory requirements.
Objectives :
Main Objective of the DMF is to support regulatory requirements
To prove the quality, safety and efficacy of the medicinal product
TYPES OF DMF :
DMF FORMAT & ASSEMBLY :
The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs
Multiple volumes are numbered, and the paper must be standard paper size
Paper length should not be less than 10 inches nor more than 12 inches.
Each volume of a DMF should be not more than 2 inches thick
DELIVERY OF DMF TO FDA :
DMF should be submitted at following address :
Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA
SUBMISSION OF DMF :
The DMF must be submitted in two copies, one with a blue cover and one with a red cover.
Each page of each copy of the DMF should be dated and consecutively numbered.
Each DMF submission should contain :
• A Transmittal letter
• Administrative information about the submission
• Other specific information
A. Transmittal Letter :
i) Original Submissions :
• Identification of submission: Original, the type of DMF as classified in Section III, and its subject.
• Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
ii) Ammendments :
• Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment.
• A description of the purpose of submission, e.g., update, revised formula, or revised process.
• Signature of the holder or the authorized representative.
• Typewritten name and title of the signer.
B. Administrative information about the submission:
The document discusses post-approval changes that can be made to approved NDAs and ANDAs. It describes four reporting categories for post-approval changes based on their potential impact: major changes requiring prior approval, moderate changes reported via a CBE-30 or CBE-0 supplement, minor changes reported annually. Examples are provided for different types of changes that fall under each reporting category. The levels of reporting ensure that manufacturers can make certain changes while providing appropriate notification to the FDA depending on the level of change.
The document provides an overview of efforts to implement the Pharmaceutical Manufacturing Plan for Africa (PMPA) through the African Medicines Regulatory Harmonization initiative (AMRH). It discusses:
1) The background and principles of PMPA which aim to strengthen Africa's pharmaceutical industry and regulatory systems.
2) Challenges in Africa's pharmaceutical value chain like ineffective regulation and technical barriers.
3) NEPAD Agency's role in supporting PMPA implementation through policy/regulatory reforms and capacity development under AMRH.
4) Progress made in establishing AMRH projects across African regions to harmonize medical product registration and regulatory functions.
5) The vision for A
Presentation by medicines registration harmonisation in the SADC made at the Euro-Africa Health Investment Conference, March 26 - 27, 2013, London, United Kingdom.
The document summarizes the work of the Africa Capacity Alliance (ACA) in facilitating public-private partnerships in health. ACA is a network of 37 member institutions across 12 countries that aims to build capacity in health systems strengthening, community systems strengthening, and public-private partnerships. One of ACA's strategic objectives is to foster PPPs through technical support, skills enhancement, and facilitating engagement between partners. The document outlines ACA's history since 1997, strategic pillars and projects including the Network for Africa platform and partnerships with the Center for Health Market Innovations to identify and connect health innovations with funders. It describes ACA's roundtable discussions to strengthen the health market for maternal and child health through partnerships between innovators
The document discusses the structure and progress of the Ecological Organic Agriculture Initiative in Africa. It provides:
1) An overview of the initiative's goal, vision, mission and strategic areas to promote ecologically sound agriculture practices across Africa.
2) Details on the structure of the initiative including the Continental Steering Committee established to guide implementation and composed of representatives from various stakeholders.
3) An update on achievements of the Continental Steering Committee so far, which include supporting regional organic conferences, training programs, and providing guidance to regional structures to further the initiative.
This document presents the final report of a study on strengthening pharmaceutical innovation in Africa. It provides an evidence base and direction for an initiative endorsed by Africa's ministers of science and technology to help countries develop strategies and build capacity for pharmaceutical innovation. The report analyzes the context, assesses the current landscape, identifies essential building blocks, and provides tools - including a Pharmaceutical Innovation Framework and Grid - to guide countries in developing pharmaceutical innovation systems.
The document outlines the Partnership for Aflatoxin Control in Africa's (PACA) strategy to address the aflatoxin challenge in Africa. PACA works at the continental, regional, and country levels. At the continental level, PACA focuses on knowledge management, convening stakeholders, and mainstreaming aflatoxin control into frameworks. At the regional level, PACA collaborates with Regional Economic Communities to harmonize regulations and support country planning. At the country level, PACA helps develop evidence-based country plans to build government capacity for implementation and monitoring over multiple years. PACA takes a phased approach starting with pilot countries to systematically address the complex issue of aflatoxin contamination across Africa.
The document outlines strategic priorities for controlling aflatoxins in Africa. It discusses the impacts of aflatoxins on public health, food/nutrition security, and trade. The Partnership for Aflatoxin Control in Africa (PACA) was created to advocate and coordinate aflatoxin control across the continent. PACA's strategy involves activities at the continental, regional, and country levels. At each level, PACA aims to strengthen policies, build capacity, increase awareness, and support the development and adoption of solutions to reduce aflatoxin contamination in Africa.
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This document provides an overview of regulatory harmonization efforts in ASEAN and opportunities for further development. It discusses the establishment of the Centre of Regulatory Excellence (CoRE) to strengthen regulatory leadership, promote innovation, and develop regulatory networks in Asia. CoRE aims to enhance regulatory capabilities and systems through education programs, collaboration, and serving as a neutral platform to ensure timely access to safe, effective medical products for patients in the region. The document identifies opportunities to further improve regulatory processes, infrastructure, and convergence of requirements across ASEAN.
The SADC AIDS WATCH AFRICA (AWA) Summit was held to discuss progress and challenges in HIV/AIDS, TB, and malaria in the region. Key issues discussed included logistical, financial, and human rights barriers to testing and treatment, as well as the importance of nutrition in disease management. The Summit directed SADC countries to develop strategies to address these challenges, including lobbying for increased global health funding, promoting local drug production and procurement, and creating a SADC nutrition strategy. Ministers of Health were tasked with presenting recommendations on implementing solutions at the next SADC Summit in 2014.
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This document proposes a framework for documenting and sharing best practices in sexual and reproductive health (SRH) in the Southern African Development Community (SADC) region. It summarizes findings from a desk review of SRH practices, guidelines, and progress in SADC member states. The review found limited systematic documentation and sharing of SRH best practices. The proposed framework would establish standardized criteria and processes for identifying, documenting, and exchanging SRH best practices to promote their adoption across the region. It outlines recommendations on SRH policies, practices, and a structure for the framework that defines essential criteria and integration into programming.
ICH GCP guidelines for mpharmacy 2nd sem 204T subject.
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The document discusses the Comprehensive Africa Agriculture Development Programme (CAADP) framework and country implementation process. It provides an overview of CAADP's vision and goals to improve agricultural productivity, integrate farmers into markets, and improve livelihoods through evidence-based country strategies and investments. It outlines the key steps in the country implementation process, including stakeholder engagement, analysis, development of investment programs, and monitoring. It describes FARA's role in providing technical support through human and institutional capacity building, advocacy, and partnerships to ensure countries benefit from agricultural research and innovation under CAADP.
Push for greater R&D and innovation in AfricaPharmaAfrica
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the day was celebrated across the world with the hosting of major national events, seminars, and press and media coverage, to communicate the value of accreditation to Government, Regulators and the leaders of the business community.
What international support for quality improvement is available to Lesotho national health care initiatives?
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This document outlines an IWMI Africa Uptake Strategy. It defines research uptake as the effective utilization of research-based evidence by decision makers. The strategy aims to have a clear impact, demonstrate the value of IWMI's research, and achieve greater success. Key elements include engaging target audiences like policymakers, packaging outputs, and monitoring outcomes. Implementation occurs at the project level and by developing knowledge products and engaging with groups like NEPAD, FARA, and national governments to influence policy and irrigation practices. The strategy recognizes limitations like directly impacting end users.
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4. New Partnership for Africa’s Development
(NEPAD)
• 2001: A Programme of the African Union (AU) adopted in
Lusaka, Zambia
• February 2010: Integration of NEPAD under the AU structures
• Re-newed mandate as a technical body of the African Union
to:
• Facilitate and coordinate the implementation of the
continental and regional programmes and projects;
• Mobilize resources and partners in support of the
implementation of Africa’s priority programmes and
projects;
• Conduct and coordinate research and knowledge
management;
• Coordinate the implementation of programmes and
projects, &
• Advocate on the AU and NEPAD vision, mission and core
principles/values
5. Est.: OAU – May 1963 AU – July 2002
Tel: +251-11 551 77 00 Fax: +251-11 551 78 44 Website: www.africa-union.org
Head Office Address: P.O. Box 3243, Roosevelt Street (Old Airport Area), W21K19, Addis Ababa,
Ethiopia
Algeria
Libya
Benin
Madagascar
Botswana
Created by: Mrs. Andriëtte Ferreira – NEPAD Secretariat, 1258 Lever Road, Headway
Hill, Midrand, Johannesburg, South Africa, Email: andriettef@nepad.org
Information source: www.africa-union.org
Angola
Malawi
Burkina Faso
Mali
Burundi
Mauritania
Cameroon
Mauritius
Cape Verde
Mozambique
C/African Rep.
Namibia
Chad
Niger
Comoros
Nigeria
DRC
Rwanda
Congo
Sharawi Arab DR
Côte d’Ivoire
São Tomé & Prínc.
Djibouti
Senegal
Egypt
Seychelles
Equatorial Guinea
Sierra Leone
Eritrea
Ethiopia
Gabon
Gambia
Ghana
Guinea
Guinea-Bissau
Kenya
Lesotho
Liberia
Somalia
South Africa
Sudan
Swaziland
Tanzania
Togo
Tunisia
Uganda
Zambia
6. African Union
• 54 member states of the African Union
– fifty two republics, and two kingdoms
– South Sudan is the newest member state, joining on 2011
July 27
• Total population: ~ 1 billion
• 8 Regional Economic Communities:
– Arab Maghreb Union (UMA), Common Market for Eastern and
Southern Africa (COMESA), Community of Sahel Saharan States (CENSAD), East African Community (EAC), Economic Community of Central
African States (ECCAS), Economic Community of West African States
(ECOWAS), Intergovernmental Authority on Development (IGAD) and
Southern Africa development Community (SADC)
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6
7. PMPA-AMRH Genesis
African Union Assembly Decision 55 of 2005 - Abuja Summit:
African Union Commission (AUC) to develop a Pharmaceutical
Manufacturing Plan for Africa (PMPA) within the NEPAD Framework
Aim: to contribute to a sustainable supply of quality essential medicines
to improve public health and promote industrial and economic
development on the continent
Critical elements for successful implementation of PMPA :
Legislative framework: Sound regulatory systems e.g. GMP, GDP, GCP
e.t.c.
Full use of TRIPS and related flexibilities
Appraisal of technical feasibility and financial viability
A market size to ensure sustainability
Technology transfer
Human resource
Duties and taxes
7
9. AMRH VISION & MISSION
VISION:
African people have access to essential medical
products and technologies
MISSION:
Provide leadership in creating an enabling
regulatory environment for pharmaceutical
sector development in Africa
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9
10. AMRH Strategic Directions
• Policy and Regulatory Reforms
– Increased use of harmonized policies and regulatory frameworks
by member states
• Regulatory capacity Development
– Increased human and institutional capacity for regulation of
medical products and technologies
– Use of existing structures & institutions to ensure sustainability
• Knowledge Management
– Knowledge assets on medicines regulation at country, regional
and continental levels created
• Enabling environment for AMRH
– Governance & coordination
– Partnership Platform Accountability Framework
– M&E and impact assessment framework
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10
11. Consortium of key partners established to accelerate and
ensure African Medicines Regulatory Harmonization
(AMRH)
Consortium Partners
NMRA Representatives
Other Stakeholders
COHRED
Consortium and major
stakeholders convened in
February and November
2009
Regional Economic Communities and Organizations (RECs)
•
•
Unanimous consensus emerged: now is the right time to push for regulatory
harmonization in Africa
Global Medicines Regulatory Harmonization - Multi-Donor Trust Fund established
under the World Bank
11
12. AMRH Partners….
Political/Technical/Operat
AMRH Partners Roles
ional
•
•
•
•
•
New Partnership for Africa’s
Development (NEPAD Agency)
African Union Commission
(AUC)
Pan African Parliament (PAP)
World Health Organization
(WHO)
The World Bank
Donors & NGOs
•
•
•
Bill & Melinda Gates
Foundation
UK Department for
International Development
(DFID)
Clinton Health Access Initiative
(CHAI)
• Mobilising political support, and
financial and technical resources for
AMRH programme
• Promoting and facilitating inter-REC
communication, coordination, technic
al consistency and shared learning
• Building a continental
initiative, assisting in priority setting
and plans for regulatory
harmonization
12
13. AMRH…
• Overall Objective
– To improve public health by increasing access to quality,
safe and efficacious essential medicines for the
treatment of priority diseases
– Contribute to socio-economic development agenda for
Africa
• Specific Objective
– To reduce the time taken to register priority medicines
– Registration as pathfinder to a broader
harmonization of other regulatory functions and
products
13
15. AMRH …
~ 54 National Medicines Regulatory Authorities (NMRAs) governing medicines regulation
across Africa
Today
Lack/inadequate medicines policies and laws
Regulators' capacity highly variable: Financial, HR, Institutional
Different requirements and formats, lack of clear guidelines
Minimal transparency, No clear timelines
Reference evaluations1 underleveraged
Between 5-7 regional economic communities (RECs)
covering the entire African continent1
Streamlined
(harmonized)
future
Harmonized medicines policies and Laws
Stronger, institutionalized regulatory capacity & systems
strengthening programmes
Earlier
approval
of more
medicines &
vaccines
Single set of requirements, Clear guidelines, Fewer
dossiers to prepare
Transparent regulatory processes with clear timelines
Resource pooling and information sharing
1. WHO prequalification, Article 58 positive opinions, stringent regulatory approval, certificate of pharmaceutical product (CPP)
15
15
16. Critical Milestones
1. Harmonised requirements and standards
Fully Harmonised
Not Harmonised
Member States
Operating
independently
Member States
Collaborate on selected
topics
Harmonised
standards and
broad collaboration
Centralized
Procedure
• each country has
its own technical
requirements
and format for
registration
applications
Regional harmonised
guidelines & procedures:
• Guidelines for
registration of
medicines
• Procedures for
evaluation of
medicines
• GMP guidelines &
Inspection procedures
•
Centralized
registration on
behalf of
participating
member states
•
•
•
Joint evaluations
and inspections
Sharing
assessment and
inspection reports
Quality
Management
Systems
Information
Management
Systems
Regional
Medicines
Agencies e.g. EACMFSA
National sovereignty is respected:
Medicines registration decisions remaining firmly that of sovereign nations
Robust & transparent regulatory processes
16
17. Critical Milestones
2. Regulatory capacity development
Ad-hoc training programmes
Working Member States
independ Collaborate on
ently
training
programmes
Existing
training
program
mes for
NMRA
staff
based on
donor
funding
Institutionalised training programmes
Harmonised training
standards and broad
collaboration
• Evaluation &
registration of
medicines
• GMP
Inspections
• Quality
Management
Systems
• Management
Information
Systems
•
Utilise Existing Regional structures
& expertise: NMRAs & Academic
institutions
• Harmonised
training curriculum
• Certification
• Evaluation of
training
programmes
• Potential partners:
Short Term:
• Twinning/Exchange
programmes among NMRAs
within & outside the continent
• Regional Centres of Regulatory
Excellence (RCORE)
Long-Term:
• Engagement of academic
institutions to offer post
graduate courses in Regulatory
Science
WHO, US-FDA,
PQM, AfDB,
EDCTP, ANDi,
PDPs, SIAPS
Increased regulatory workforce in Africa
17
18. Critical Milestones
3. Policy and Regulatory Reforms
Inadequate policies & laws
Harmonised policies & Laws
Current status
Country level
• Lack/Weak
medicines laws
• Medicines
regulated within
territories
• Varying
comprehensivenes
s of laws
• No sanctions on
non compliance to
regional treaties
• Adoption
• Binding
• At least 5 regions have
and
regional
adopted regionally
domesticati
legal
harmonized policies and
on of model
instruments
legislative frameworks
law on
• At least 20 countries
medicines
implementing the regionally
regulation
harmonized policies and
legislative frameworks
• Mutual
• At least 2 regional medicines
recognition
agencies established
agreements
•
Regional level
Continental level
Increased adoption of regionally agreed standards
• Mutual recognition of regulatory decisions
18
20. 1. GMRH Multi-Donor Trust Fund
• The World Bank administration of a Global Medicines
Regulatory Harmonization Multi-Donor Trust Fund
(GMRH-MDTF)
• Initial funds to cover EAC Medicines Registration
Harmonization Project and AMRH Partners
• US$ 12.5 million
• Bill & Melinda Gates Foundation provided initial start-up
grant while other interested donors are engaged
• Strategically mobilize resources to cover other RECs
• Sustainable domestic financing options
20
20
21. 2. CONTINENTAL PROGRESS
• AMRH Advisory Committee established
– NEPAD Agency Secretariat: Coordination and Political advocacy
– Provides strategic and policy advise on AMRH programme
implementation
– Composed of representatives from RECs, NMRAs, AUC, PAP,
NEPAD, WHO, World Bank, industry associations, civil society
• Technical Working Groups
– Regulatory Capacity Development
– Medicines Policies & Regulatory Reforms
• Draft Model Law for Medicines Regulation Harmonization
in Africa developed
– Stakeholders consultations planned for 2013
12/25/2013
21
22. CONTINENTAL PROGRESS…
Related Continental Frameworks
• July 2012: 19th AU Assembly decision on Roadmap for
Shared Responsibility and Global solidarity for the
AIDS, TB and Malaria response in Africa
– Emphasis - accelerate and strengthen regional
medicines regulatory harmonization initiatives
– Establishment of regional medicines agencies
– Foundation for a single African Regulatory Agency
– Lead Partners: AUC, UNAIDS & NEPAD Agency
22
23. 3. REGIONAL PROGRESS
East African Community
•
Launch & subsequent implementation of EAC Medicines Registration
Harmonization (MRH) Project since March 2012
•
5 EAC Partner States (6 NMRAs) participating in the AMRH Initiative:
Burundi, Kenya, Rwanda, Tanzania, Uganda
•
MRH Project Steering Committee Established
•
Technical Working Groups (TWG) established to develop registration
and GMP guidelines and procedures in line with internationally
acceptable standards
•
Partner States NMRAs taking lead
•
•
•
•
Tanzania: TWG on medicines evaluation & registration
Uganda: TWG on good manufacturing inspection
Kenya: TWG on quality management systems
Rwanda: TWG on Information Management System (IMS)
23
23
24. REGIONAL PROGRESS…
West African region:
• 15 participating member states
• 2011: Development of MRH Project framework in
consultation with industry
• August – Nov 2012:
– WAHO, UEMOA, WHO & NEPAD Agency High Level consultation
meetings
– Experts consultation meetings
– WAHO engagement of 7 countries (5 Anglophone & 2 Lusophone)
– UEMOA engagement of 8 Francophone countries
• 2013: WAHO/UEMOA Regional coordination framework, plan of action
and Memorandum of Understanding
24
25. REGIONAL PROGRESS…
Central African region
• 10 participating member states
• 2009-11: Situation analysis and development
of a project framework for OCEAC/ECCAS
• 2012: Consultation with OCEAC and ECCAS
• 2013: Consultation on OCEAC/ECCAS
Regional coordination framework, plan of
action and memorandum of understanding
25
26. 4. PHARMA INDUSTRY PARTICIPATION
• 2010-2012: NEPAD commissioned situation
analysis of medicines regulation & harmonization
across African RECs and countries
– National & regional policy & legislative frameworks
– NMRAs assessment
• 3 categories based on agreed criteria; i) Existing NMRA; ii) Existing
legal framework; iii) performance of full regulatory functions
(registration, GMP); iv) Existing Management Information System; v)
Available HR
– Industry perception on AMRH
• Consultation through National & regional industry associations
• General agreement
• EAC, SADC, ECOWAS consultation meetings
– Development of regional MRH Frameworks
26
27. AMRH Coverage Roughly 85% of Sub-Saharan
Africa
REC Status/Progress
Countries
covered
Population
(Mill)
Pharma
market
(US$ Bill
p.a.)
EAC
ECCAS/OCEAC
ECOWAS-WAHO/UEMOA
SADC
UMA/CENSADC/COMESA/IGAD
5
10
15
15
9
133.1
120
~300
267.58
N/A
N/A
N/A
3.5 (2010)
3 (2006)
N/A
Total:
54
•
We are pushing forward with RECs that are
willing
Industry participation in stakeholders
consultation is key
National & regional industry association a good
platform for engagement
RECs
•
•
Source: BCG analysis
EAC
ECCAS/
OCEAC
SADC
27
27
28. AMRH contribution to Pharma Industry Development dev
Prevention and treatment of
infections diseases (overall)
Short term
Intermediate
term
Long term
Enhanced access to
new health technologies
Broad economic
development in the
region
Increased access to
generics treating many
important diseases
Broader, more rapid
access to vaccines and
other therapies
Extension to all regulatory
functions
More efficient
launches for vaccines and
other PDP products
Greater impact of new lifesaving technologies
Foundation for
African pharma industry
(PMPA)
• Benefit to Regional
Economic & Trade Treaties
• Increased market access
Healthier, more
productive workforce
28
28
29. 5. WAY FORWARD
• Regional Stakeholders consultation
– EAC harmonised guidelines & procedures
– AMRH Model Law
• Institutionalization of the regulatory training programmes in
the continent
– Establishment of Regional centres of regulatory Excellence
(RCOREs)
– Training for regulators & industry
– Key for sustainability
• Expanding the scope for harmonization to clinical trials
oversight and safety monitoring
• Governance and effective coordination regionally &
continentally
– Establishment of Partnership Platform Accountability Framework
– Impact assessment of policy & regulatory reforms in Africa
29
30. WAY FORWARD…
• 1st Scientific conference for medicines regulation in
Africa
– Theme:
“Building Partnerships for Sustainable Capacity Development in
Medicines Regulation in Africa”
– Target group: African regulatory authorities, researchers,
academic institutions and industry
• Necessity of working together to address socio-economic issues
affecting the African populace
– Call for Abstracts
• Read: AMRH-PMPA Policy Brief
• Visit: www.amrh.org
30
31. CONCLUSION
• AMRH is a strategic initiative for pharmaceutical sector
development in Africa
• Strong political constituency and partnerships built
– AU organs (AUC, NEPAD Agency, PAP), RECs, NMRAs,
pharmaceutical industry & Civil Society
– Donors, development partners & international agencies
• Cooperation, collaboration and commitment by all
stakeholders is key for success
– Need practical alignments & engagement between African
NMRAs, industry, academia and researchers
• EAC MRH Project provides a Model for replication to other
RECs
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31